The U.S. Court of Appeals for the 3rd Circuit ruled Oct. 21, 2005, that a company that deceptively promoted products as cancer cures must issue refunds to customers who bought the drugs. A three-judge panel unanimously upheld an earlier court ruling that required New Jersey-based Lane Labs to pay $109 in restitution to consumers who purchased their “shark cartridge” pills.

The FDA began building its case against Lane in 1997 after warning the company to stop promoting its products, which had not received FDA approval, as treatments for cancer and HIV. In 2004 a New Jersey district court held that the FDA could force the company to issue refunds to any customer who bought the product.

The 3rd Circuit upheld that decision. The ruling is a major victory for the FDA. Now the agency can demand restitution for consumers who purchased products that did not meet FDA approval. Previously the FDA only could enjoin companies from marketing unapproved drugs.